PROCEDURE
Procalcitonin measurement
Daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Status
Completed
Phase
Phase 3
Enrollment
532
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with sepsis. Trial settings Trial site is Chattogram Medical College Hospital (CMCH), Bangladesh. CMCH is tertiary care hospital with undergraduate and postgraduate teaching facilities. This tertiary hospital receives referrals from urban and rural areas of southern Bangladesh and has basic facilities for intensive care and haemodialysis. Trial Participants: Male or female hospitalised patients, 16-65 years of age, with confirmed or suspected sepsis Patients (Total 532) will be 1:1 randomised to either: * Intervention arm: daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics (Intervention arm: 266), or * Control arm: standard of practice to guide de-escalation of antibiotics without procalcitonin assessments (Control arm: 266). Patients will be followed-up until ICU discharge and/or hospital discharge with an additional follow-up at 28 days after discharge. Funder: Wellcome Trust of Great Britain Grant reference number from Wellcome Trust: 220211/A/20/Z
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jul 21, 2023
Study start
Jul 26, 2023
Primary completion
Jun 20, 2024
Study completion
Jul 30, 2024
Results posted
Not reported
Registry updated
Nov 26, 2024
Outcomes
What the study measures.
Primary outcomes
Length of antibiotic treatment
Time frame · Through study completion, an average of 1 month
number of days of antibiotic treatment during the study period.
Secondary outcomes
Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)
Time frame · Through study completion, an average of 1 month
Defined daily dose (DDD) is the assumed average maintenance dose per day for a drug used in its main indication in adults.
Days of therapy with antibiotics (DOT)
Time frame · Through study completion, an average of 1 month
Definition of DOT: One DOT represents the administration of a single antibiotic on a given day regardless of the number of doses administered or dosage strength. If a patient receives more than one antibiotic it will be added on with DOT of the first antibiotic.
Number of days of parenteral antibiotic during hospitalisation period
Time frame · Through study completion, an average of 1 month
Number of days of parenteral antibiotic from the day of enrolment to the day of stopping of parenteral antibiotic during hospitalisation period
Number of days of antibiotic treatment during the hospitalisation period.
Time frame · Through study completion, an average of 1 month
Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.
Time frame · Through study completion, an average of 1 month
Recurrent infections are classified as follows: culture-positive relapse (unsuccessful eradication of the original infecting strain), culture-negative relapse (reappearance of symptoms after antibiotics cessation with negative cultures), reinfection (infection by a different strain of the same species), and syndromic recurrence (symptoms recur post-antibiotics, regardless of culture results).
Duration of hospital stay (ICU/ general ward)
Time frame · Through study completion, an average of 1 month
Proportion of patients with infections caused by antibiotic resistant bacteria
Time frame · Through study completion, an average of 1 month
Direct medical costs of prescribed antibiotics, the assessment of serum procalcitonin (PCT assay) and hospital stay cost.
Time frame · Through study completion, an average of 1 month
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Participant, legally authorised person/ legal guardian willing and able to give informed consent for participation in the trial. * Male or Female, aged 16 to 65 years * Suspected or proven bacterial infection * A positive sepsis screening National Early Warning Score (NEWS) equal or greater than 5 (Table 1 or at least one criterion with a score of 3. * Intention to start parenteral antibiotic therapy * Within 24 hours of hospital admission Exclusion Criteria: * Patients with suspected/documented tuberculosis, parasitic infection (including malaria or visceral leishmaniasis), or viral infections (i.e., COVID-19, dengue, HIV) * Pregnancy * Intended for a short stay in ICU or general ward (such as post-operative) * Patients requiring a predefined long course of antibiotic therapy (such as endocarditis, osteomyelitis, lung abscess, liver abscess, septic arthritis) * Immunocompromised patients, including as severe neutropenia (\< 500 cells/ml), transplant recipients, on prolonged corticosteroid treatment, chemotherapy or disease modifying immunomodulatory medications * More than 48 hours of parenteral antibiotic use * Surgical patients, including patients with a surgical septic source or patients requiring source control, i.e. abscess drainage * Moribund patients or patients receiving end of life care * Previous enrolment in PROCALBAN * Conditions accompanied with a systemic inflammatory state, including pancreatitis, cardiogenic shock, severe trauma
Study locations
1 registered sites.
Bangladesh. Showing up to 24 locations stored in the fast local snapshot.
Chattogram Medical College Hospital (CMCH)
Chittagong, Chattogram, Bangladesh
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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